The US Food and Drug Administration (FDA) has granted clearance to Nkarta’s investigational new drug (IND) application, enabling the initiation of a clinical trial of NKX019 to treat lupus nephritis (LN).
The dose escalation, open-label, multi-centre trial is designed to evaluate the clinical activity and safety of the allogeneic, CD19-directed CAR NK cell therapy NKX019 in patients with refractory LN.
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It intends to enrol nearly 12 patients, with the first subject expected to be enrolled in the first half of next year.
They will receive NKX019 at one billion or 1.5 billion cells per dose on days zero, seven, and 14, following lymphodepletion with single agent cyclophosphamide.
Nkarta president and CEO Paul Hastings said: “Nkarta is well-capitalised with runway that extends into 2026 and beyond key data readouts across the three programmes.
“We plan to remain disciplined about our expenditures as we focus on execution and the multiple opportunities for near- and long-term value creation.
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By GlobalData“We’ve taken the unfortunate but necessary step to streamline our workforce and reconfigure our research and development (R&D) approach to be in the best position to advance our multiple cell therapies programmes.”
The company intends to announce clinical updates for NKX101 programmes in the first half of next year, and NKX019 later next year.
Nkarta chief medical officer David Shook said: “NKX019 is active immediately and is self-sustaining, without the need for large cytokine surges from preparative chemotherapy.
“We will continue to work closely with leading investigators to bring the promise of cell therapy to patients in need to explore this potentially transformative therapeutic approach.”
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